Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 6:39 AM
Study NCT ID:
NCT00285506
Status:
COMPLETED
Last Update Posted:
2006-05-29
First Post:
2006-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Contrast Media on Erythrocytes in Healthy Volunteers
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to test the effect that contrast media (dye) has on cellular integrity (structure)
Detailed Description:
The influence of several radiological contrast media on erythrocyte morphology and function has been investigated in the past (1). However, published data is sparse and does not include the assessment of iso-osmolar agents as compared to low-osmolar agents.
In addition, the effect of the injection of contrast media at higher temperatures (i.e. \> room or body temperature), which may be beneficial for the rapid injection of more viscous contrast media at multi detector-row CT angiography, has never been evaluated.
We intend to assess the hypothesis, that iso-osmolar contrast media (i.e. Visipaque) exerts less effect on erythrocyte morphology and function as compared to low-osmolar agents.
In addition, we intend to identify the upper temperature limit, at which contrast media can be injected, without affecting erythrocyte integrity.
Subjects will have up tp 400 mLs (approximately 26 tablespoons) of blood drawn. The blood will be kept at body temperature in a petri dish or similar container and exposed to contrast media (dye).
In addition, the effect of the injection of contrast media at higher temperatures (i.e. \> room or body temperature), which may be beneficial for the rapid injection of more viscous contrast media at multi detector-row CT angiography, has never been evaluated.
We intend to assess the hypothesis, that iso-osmolar contrast media (i.e. Visipaque) exerts less effect on erythrocyte morphology and function as compared to low-osmolar agents.
In addition, we intend to identify the upper temperature limit, at which contrast media can be injected, without affecting erythrocyte integrity.
Subjects will have up tp 400 mLs (approximately 26 tablespoons) of blood drawn. The blood will be kept at body temperature in a petri dish or similar container and exposed to contrast media (dye).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: